BIOLOGICAL WAR-FEAR
Smallpox vaccine uses
fetal cell line
Some Americans may refuse shot, worsening potential outbreak
By Jon Dougherty
© 2001 WorldNetDaily.com
A company that would use a stem-cell line from an aborted fetus to manufacture a new smallpox vaccine is one of only a few firms being considered for a major new government contract despite concerns that the use of such tissues could lead many people to refuse the shots, thereby worsening any outbreak.
The company, Acambis PLC of England, in partnership with the Centers for Disease Control and Prevention in Atlanta, has already been contracted by the federal government to make 40 million doses of the vaccine.
According to the Washington Post, that contract – signed last year – is set to increase to 54 million doses. But, as a part of a plan being formulated by the Department of Health and Human Services, the number could rise by as much as 250 million doses under new requirements to manufacture enough vaccine for every man, woman and child in the country.
Three other companies besides Acambis are being considered for the new vaccine contract, the Post reported.
The department announced earlier this month that the agency is soliciting bids for the manufacture of a new smallpox vaccine. The current stockpile, at just 15 million doses, is far from adequate should terrorists release new strains of the disease in public, HHS Secretary Tommy Thompson said.
Officials have voiced new concerns over intentional smallpox outbreaks in the wake of the Sept. 11 attacks and the outbreak of anthrax at various locations along the East Coast.
Meanwhile, health officials with the Food and Drug Administration say the method of manufacturing the old vaccine, called Dryvax, which was made by Wyeth using calf skin, is "no longer considered optimal." Instead, the agency says the new smallpox vaccine "will be prepared in MRC-5 cells" – a line of aborted fetal cells dating back to 1966 – because that method is more efficient.
"The MRC-5 line was developed … from lung tissue taken from a 14-week fetus aborted for psychiatric reasons from a 27-year-old physically healthy woman," said a description of the cell tissue by the Coriell Institute for Medical Research at the University of Medicine and Dentistry of New Jersey, where the line is maintained. The institute further describes it as "normal human fetal lung fibroblast."
The new manufacturing method has concerned some pro-life groups, who argue that the use of aborted fetal tissue could cause pro-life supporters to refuse it, making any outbreak worse in terms of duration and mortality.
"If enough people refuse the vaccine, we may be faced with serious epidemic problems," said Debi Vinnege, executive director of Children of God For Life, an organization that monitors the use of aborted fetal tissue in the manufacture of vaccines.
"There is no reason to endanger the lives of hundreds of thousands, if not millions, of Americans when perfectly acceptable alternative methods may be used to cultivate the smallpox vaccine," she told WorldNetDaily.
Lenore Gelb, a spokeswoman for the FDA, said the use of the stem-cell line for vaccine production was not new, adding that it was not up to her agency to decide who should and should not receive the vaccine.
"The FDA doesn't have that role," she said.
Asked if she was concerned about a prolonged outbreak due to the refusal by some to take the vaccine, she said, "FDA approves a vaccine based on the 'safety and effective' [criteria]." She said "recommendations for who should get a vaccine" were up to the CDC.
Smallpox 'easily transmitted'
Vaccinations to prevent smallpox have not been required in the United States since 1972, says HHS, because it was largely eliminated as a threat in the United States.
Caused by a virus known as Variola major, smallpox "is considered one of the most dangerous potential biological weapons because it is easily transmitted from person to person and because few people carry full immunity to the virus," according to department documentation.
Although a worldwide immunization program eradicated the smallpox disease in 1977, small quantities of the smallpox virus still exist in two secure facilities in the United States and Russia, the government said.
"However, it is possible that unrecognized stores of smallpox virus exist elsewhere in the world," said an HHS assessment.
"Smallpox vaccine has proven to be highly effective in preventing infection. In unvaccinated people exposed to smallpox, the vaccine can lessen the severity of, or even prevent, illness if given within four days after exposure," said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, a division of the HHS, in testimony to the Senate Appropriations Committee Nov. 2.
Nevertheless, there is obvious concern among experts that terrorist entities – as they have with anthrax – could eventually reintroduce smallpox into U.S. society. If that happens, some public health experts say extreme measures would be needed to combat the threat.
One such plan is already in the works. Last month, all 50 state governors were sent a copy of a proposal that, if passed into law, would grant each of them new authority to act in the event of a health emergency like a smallpox outbreak.
According to the report, the measure would allow governors – upon the declaration of a health emergency – to invoke the authority to order roads and airports closed, to quarantine entire cities, and to move people to holding facilities like sports stadiums, if need be, to protect the rest of the public from becoming infected.
"In tough times, you have to make tough decisions," Paul Jacobsen, assistant commissioner for the Massachusetts Department of Public Health, told the Boston Herald Monday.
One of those "extreme measures" could be compulsory vaccination, some worry. Under the proposal, even those who philosophically disagree with the ingredients of the vaccine may, under extreme measures, be vaccinated against their will for the good of an entire community.
Nevertheless, April Bell, a spokeswoman for the CDC, told WorldNetDaily that the United States does not currently have a mandatory vaccination requirement. Also, she said that in the event of widespread infection, universal vaccination may not even be necessary.
Under the epidemiological concept of "herd immunity," Bell said, "you would vaccinate around the case. If some people refused to be vaccinated, you vaccinate those they were in contact with," thereby isolating the spread of the disease.
"That's how smallpox was eradicated in the first place," she said, adding that smallpox carries a relatively low – 30 percent – mortality rate.
Bell said the CDC had no position on the state emergency health powers legislation. However, according to Lawrence O. Gostin, director of the Center for Law and the Public's Health at Johns Hopkins and Georgetown Universities, the author of the measure, the "act ensures a strong, effective and timely response to public health emergencies … without unduly interfering" with civil rights and liberties.
"Emergency health threats, including those caused by bioterrorism and epidemics, require the exercise of extraordinary government functions," he wrote in a preamble introduction to his 40-page "model" bill.
The bill was drafted in collaboration with the National Governor's Association, National Conference of State Legislatures, National Association of Attorneys General and the National Association of City and County Health Officers.
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